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Open-label Trial to Check the Safety and Tolerability of RTX-GRT7039 Injections for Pain Associated With Osteoarthritis of the Knee

Primary Purpose

Osteoarthritis

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
RTX-GRT7039
Sponsored by
Grünenthal GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis focused on measuring Knee, Osteoarthritis, Pain assessment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • The participant has given written informed consent to participate.
  • The participant is 18 years of age or older at the Screening Visit.
  • The participant has a diagnosis of osteoarthritis of the knee based on American College of Rheumatology criteria and functional capacity class of I to III.
  • There is a documented history indicating that participant has insufficient pain relief with previous Standard of Care.

Exclusion Criteria:

  • The participant has past joint replacement surgery of the index knee.
  • The participant has a history of significant trauma or surgery (e.g., open or arthroscopic) to the index knee within 12 months of Screening.
  • The participant has periarticular pain at the index knee from any cause other than osteoarthritis, including referred pain, bursitis, tendonitis.
  • The participant has clinical hip osteoarthritis on the side of the index knee.
  • The participant has a history of osteonecrosis, subchondral insufficiency fracture, atrophic osteoarthritis, rapidly progressing osteoarthritis (RPOA) Type I or Type II,pathologic fracture, primary or metastatic tumor, or joint infection in the index knee.
  • The participant has significant malalignment of anatomical axis (medial angle formed by the femur and tibia) of the target knee (varus >10°, valgus >10°) by radiograph as assessed by independent Central Readers at Screening Visit.
  • The participant has other conditions that could affect trial endpoint assessments of the index knee.
  • The participant has current clinically significant disease(s) or condition(s) that may affect safety assessments, or any other reason which may preclude the participant's participation for the full duration of the trial.
  • The participant has a history of hypersensitivity to resiniferatoxin (RTX) or any similar component (capsaicin, chili peppers).
  • The participant is currently participating or was participating in another investigational drug trial within 3 months prior to the Screening Visit.
  • The participant is an employee of the investigator or trial site, with direct involvement in the proposed trial or other trials under the direction of that investigator or trial site or is a family member of the employees or the investigator.

The non-index knee is not eligible for treatment in the trial, if any of the knee-related exclusion criteria applies to the non-index knee.

Sites / Locations

  • Arizona Arthritis and Rheumatology Associates (AARA) P.C
  • Elite Clinical Studies, LLC
  • Orange County Research Institute
  • Acclaim Clinical Research, Inc.
  • Westlake Medical Research
  • Progressive Medical Research
  • Gulfcoast Research Institute
  • Palm Beach Research Center
  • North Georgia Clinical Research
  • Injury Care Research
  • Chicago Clinical Research Institute Inc.
  • OrthoIndy, Inc.
  • University Of Kansas Medical Center
  • Neuroscience Research Center, LLC
  • Clinical Pharmacology Study Group
  • Oakland Medical Research Center
  • Excel Clinical Research
  • Las Vegas Clinical Trials, LLC
  • Drug Trials America
  • M3-Emerging Medical Research, LLC
  • M3-Emerging Medical Research, LLC
  • University Orthopedics Center
  • Coastal Carolina Research Center
  • Coastal Carolina Research Center
  • Accellacare-Knoxville
  • Tekton Research, Inc.
  • Wasatch Clinical Research
  • UMHAT Eurohospital Plovdiv OOD
  • Medical Centre Artmed
  • UMHAT Pulmed
  • Medical Centre N. I. Pirogov EOOD
  • MHAT St Iv. Rilski
  • Synexus Medical Center Sofia
  • Fukuoka University HospitalRecruiting
  • Kitakyushu General HospitalRecruiting
  • Medical Corporation Kouhoukai Takagi HospitalRecruiting
  • Hakodate Central General Hospital
  • Saiseikai Kanagawaken HospitalRecruiting
  • Otakibashi Orthopedic ClinicRecruiting
  • Saitama Medical CenterRecruiting
  • Centrum Medyczne Novumed
  • ClinicMed Daniluk, Nowak Spolka komandytowa
  • Zaklad Opieki Zdrowotnej w Boleslawcu
  • Centrum Kliniczno
  • NZOZ Medi Spatz
  • Medyczne Centrum Hetmanska
  • PZU Zdrowie S.A. Oddzia¿ Centrum Medyczne Artimed w Kielcach
  • Centrum Medyczne Semper fortis
  • Centermed Krakow Sp. z o.o.
  • ETYKA Osrodek Badan Klinicznych
  • RCMed Piotr Opadczuk
  • Lubelskie Centrum Diagnostyczne
  • Europejskie Centrum leczenia Chorob Cywilizacyjnych
  • ETG Warszawa
  • Spitalul Judetean Caracal
  • SC Medicali's SRL
  • SC Medaudio-Optica SRL
  • Centrul Medical de Diagnostic si Tratament Ambulatoriu Neomed SRL
  • Spital Clinic Dr I Cantacuzino
  • SC Policlinica CCBR SRL
  • SC Centrul Medical Sana SRL
  • Spitalul Clinic Sf. Maria
  • Tread Research
  • Josha Research
  • Welkom Clinical Trial Centre
  • Worthwhile Clinical Trials
  • Midrand Medical Centre
  • Global Clinical Trials
  • University of Pretoria
  • Roodepoort Medicross Clinical Research Centre
  • Sandton Medical Research (Newtown CRC)
  • Clinresco Centres (Pty) Ltd.
  • Dr Zubar Fazal Ahmed Vawda MD
  • Synapta Clinical Research Center
  • Precise Clinical Solutions
  • Aliwal Shoal Medical Centre
  • Medicross Langeberg Medical & Dental Centre
  • Arthritis Clinical Research CentreRecruiting
  • Accellacare Yorkshire
  • Accellacare Warwickshire
  • Chapel Allerton Hospital - Leeds Teaching Hospitals NHS Trust

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

RTX-GRT7039

Arm Description

Participants will receive up to 5 intra-articular injections of RTX-GRT7039 into either the index knee (affected knee or in case of bilateral OA the knee with highest pain intensity), or each of both knees up to Week 52.

Outcomes

Primary Outcome Measures

Number of Participants With Treatment Emergent Adverse Events (TEAEs)

Secondary Outcome Measures

Number of Participants With Treatment Emergent Adverse Events (TEAEs) Representing Structural Changes as Assessed by Imaging Methods
Change from Baseline in WOMAC Pain Subscale Score
The WOMAC pain subscale will be assessed using an 11-point numerical rating scale (NRS), where 0= no pain and 10=worst pain.
Change from Baseline in WOMAC Physical Function Subscale Score
The WOMAC physical function subscale will be assessed using 11-point NRS, where 0= no difficulty and 10=extreme difficulty.
Change from Baseline in WOMAC Stiffness Subscale Score
The WOMAC stiffness subscale will be assessed using an 11-point NRS, where 0= no stiffness and 10= extreme stiffness.
Change from Baseline in WOMAC A1 (Walking Pain) Score
The WOMAC A1 score will be assessed using an 11-point NRS, where 0= no pain and 10=worst pain.
Change from Baseline in WOMAC Total Score
The WOMAC total score will be calculated as the sum of pain subscale score, stiffness subscale score and physical function subscale score. It will be calculated by averaging all of the scores available for the questions and assessed using an 11-point NRS, where 0=best outcome and 10=worst outcome.
Percentage of Participants With at Least 30%, 50% and 70% Reduction From Baseline in WOMAC Pain Subscale Score
The WOMAC pain subscale will be assessed using an 11-point NRS, where 0= no pain and 10=worst pain.
Percentage of Participants With at Least 30%, 50% and 70% Reduction From Baseline in WOMAC A1 (Walking Pain) Score
The WOMAC A1 score will be assessed using an 11-point NRS, where 0= no pain and 10=worst pain.
Percentage of Participants Categorized by Each Patient Global Impression of Change (PGIC) Score
The 7-point PGIC is a complementary assessment of analgesic efficacy on a 7-point scale where 1 = "Very much improved" and 7 = "Very much worse".
Change From Baseline in Patient-Specific Functional Scale (PSFS)
The PSFS scale will be assessed using an 11-point NRS, where 0= Unable to perform activity and 10=Able to perform activity at the same level as before your osteoarthritis of the knee started.
Change From Baseline in EuroQol-5 Dimension Health Questionnaire 5 Levels (EQ-5D-5L) Score
EQ-5D consists of EQ-5D descriptive system (Index score) and EQ visual analogue scale (VAS). EQ-5D-5L Index Score ranges from 0 to 1, with 0 representing death and 1 representing perfect health. EQ-5D-5L-VAS records participant's self-rated health on a vertical VAS that range from 0 (worst imaginable) to 100 (best imaginable).
Change From Baseline in 36-Item Short-Form (SF-36) Domain Scores
The 8 SF-36 domain scores range from 0 (worst value) to 100 (best value), with higher scores reflecting better health status.

Full Information

First Posted
May 12, 2022
Last Updated
September 25, 2023
Sponsor
Grünenthal GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT05377489
Brief Title
Open-label Trial to Check the Safety and Tolerability of RTX-GRT7039 Injections for Pain Associated With Osteoarthritis of the Knee
Official Title
A Single-arm, Open-label, Phase III Trial to Evaluate the Safety and Tolerability of Intra-articular Injections of RTX-GRT7039 in Subjects With Moderate to Severe Pain Associated With Osteoarthritis of the Knee.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 26, 2022 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Grünenthal GmbH

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
An open-label, single-arm clinical trial to confirm the safety of monoarticular injections or bi-lateral intra-articular injections of RTX-GRT7039 in patients who have pain associated with osteoarthritis of the knee despite standard of care.
Detailed Description
This trial comprises a total observation period of up to 78 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
Keywords
Knee, Osteoarthritis, Pain assessment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
930 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
RTX-GRT7039
Arm Type
Experimental
Arm Description
Participants will receive up to 5 intra-articular injections of RTX-GRT7039 into either the index knee (affected knee or in case of bilateral OA the knee with highest pain intensity), or each of both knees up to Week 52.
Intervention Type
Drug
Intervention Name(s)
RTX-GRT7039
Intervention Description
RTX-GRT7039 monoarticular injections or bilateral intra-articular injections.
Primary Outcome Measure Information:
Title
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Time Frame
From Baseline up to Week 78
Secondary Outcome Measure Information:
Title
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Representing Structural Changes as Assessed by Imaging Methods
Time Frame
From Baseline up to Week 78
Title
Change from Baseline in WOMAC Pain Subscale Score
Description
The WOMAC pain subscale will be assessed using an 11-point numerical rating scale (NRS), where 0= no pain and 10=worst pain.
Time Frame
From Baseline up to Week 12
Title
Change from Baseline in WOMAC Physical Function Subscale Score
Description
The WOMAC physical function subscale will be assessed using 11-point NRS, where 0= no difficulty and 10=extreme difficulty.
Time Frame
From Baseline up to Week 12
Title
Change from Baseline in WOMAC Stiffness Subscale Score
Description
The WOMAC stiffness subscale will be assessed using an 11-point NRS, where 0= no stiffness and 10= extreme stiffness.
Time Frame
From Baseline up to Week 12
Title
Change from Baseline in WOMAC A1 (Walking Pain) Score
Description
The WOMAC A1 score will be assessed using an 11-point NRS, where 0= no pain and 10=worst pain.
Time Frame
From Baseline up to Week 12
Title
Change from Baseline in WOMAC Total Score
Description
The WOMAC total score will be calculated as the sum of pain subscale score, stiffness subscale score and physical function subscale score. It will be calculated by averaging all of the scores available for the questions and assessed using an 11-point NRS, where 0=best outcome and 10=worst outcome.
Time Frame
From Baseline up to Week 12
Title
Percentage of Participants With at Least 30%, 50% and 70% Reduction From Baseline in WOMAC Pain Subscale Score
Description
The WOMAC pain subscale will be assessed using an 11-point NRS, where 0= no pain and 10=worst pain.
Time Frame
From Baseline up to Week 12
Title
Percentage of Participants With at Least 30%, 50% and 70% Reduction From Baseline in WOMAC A1 (Walking Pain) Score
Description
The WOMAC A1 score will be assessed using an 11-point NRS, where 0= no pain and 10=worst pain.
Time Frame
From Baseline up to Week 12
Title
Percentage of Participants Categorized by Each Patient Global Impression of Change (PGIC) Score
Description
The 7-point PGIC is a complementary assessment of analgesic efficacy on a 7-point scale where 1 = "Very much improved" and 7 = "Very much worse".
Time Frame
From Baseline up to Week 12
Title
Change From Baseline in Patient-Specific Functional Scale (PSFS)
Description
The PSFS scale will be assessed using an 11-point NRS, where 0= Unable to perform activity and 10=Able to perform activity at the same level as before your osteoarthritis of the knee started.
Time Frame
From Baseline up to Week 12
Title
Change From Baseline in EuroQol-5 Dimension Health Questionnaire 5 Levels (EQ-5D-5L) Score
Description
EQ-5D consists of EQ-5D descriptive system (Index score) and EQ visual analogue scale (VAS). EQ-5D-5L Index Score ranges from 0 to 1, with 0 representing death and 1 representing perfect health. EQ-5D-5L-VAS records participant's self-rated health on a vertical VAS that range from 0 (worst imaginable) to 100 (best imaginable).
Time Frame
From Baseline up to Week 12
Title
Change From Baseline in 36-Item Short-Form (SF-36) Domain Scores
Description
The 8 SF-36 domain scores range from 0 (worst value) to 100 (best value), with higher scores reflecting better health status.
Time Frame
From Baseline up to Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The participant has given written informed consent to participate. The participant is 18 years of age or older at the Screening Visit. The participant has a diagnosis of osteoarthritis of the knee based on American College of Rheumatology criteria and functional capacity class of I to III. There is a documented history indicating that participant has insufficient pain relief with previous Standard of Care. Exclusion Criteria: The participant has past joint replacement surgery of the index knee. The participant has a history of significant trauma or surgery (e.g., open or arthroscopic) to the index knee within 12 months of Screening. The participant has periarticular pain at the index knee from any cause other than osteoarthritis, including referred pain, bursitis, tendonitis. The participant has clinical hip osteoarthritis on the side of the index knee. The participant has a history of osteonecrosis, subchondral insufficiency fracture, atrophic osteoarthritis, rapidly progressing osteoarthritis (RPOA) Type I or Type II,pathologic fracture, primary or metastatic tumor, or joint infection in the index knee. The participant has significant malalignment of anatomical axis (medial angle formed by the femur and tibia) of the target knee (varus >10°, valgus >10°) by radiograph as assessed by independent Central Readers at Screening Visit. The participant has other conditions that could affect trial endpoint assessments of the index knee. The participant has current clinically significant disease(s) or condition(s) that may affect safety assessments, or any other reason which may preclude the participant's participation for the full duration of the trial. The participant has a history of hypersensitivity to resiniferatoxin (RTX) or any similar component (capsaicin, chili peppers). The participant is currently participating or was participating in another investigational drug trial within 3 months prior to the Screening Visit. The participant is an employee of the investigator or trial site, with direct involvement in the proposed trial or other trials under the direction of that investigator or trial site or is a family member of the employees or the investigator. The non-index knee is not eligible for treatment in the trial, if any of the knee-related exclusion criteria applies to the non-index knee.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Director clinical trials
Phone
+49 241 569
Ext
3223
Email
clinical-trials@grunenthal.com
Facility Information:
Facility Name
Arizona Arthritis and Rheumatology Associates (AARA) P.C
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85306
Country
United States
Individual Site Status
Completed
Facility Name
Elite Clinical Studies, LLC
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85018
Country
United States
Individual Site Status
Completed
Facility Name
Orange County Research Institute
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Individual Site Status
Completed
Facility Name
Acclaim Clinical Research, Inc.
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Individual Site Status
Completed
Facility Name
Westlake Medical Research
City
Thousand Oaks
State/Province
California
ZIP/Postal Code
91360
Country
United States
Individual Site Status
Completed
Facility Name
Progressive Medical Research
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32127
Country
United States
Individual Site Status
Completed
Facility Name
Gulfcoast Research Institute
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34232
Country
United States
Individual Site Status
Completed
Facility Name
Palm Beach Research Center
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
Individual Site Status
Completed
Facility Name
North Georgia Clinical Research
City
Woodstock
State/Province
Georgia
ZIP/Postal Code
30189
Country
United States
Individual Site Status
Completed
Facility Name
Injury Care Research
City
Boise
State/Province
Idaho
ZIP/Postal Code
83713
Country
United States
Individual Site Status
Completed
Facility Name
Chicago Clinical Research Institute Inc.
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60607
Country
United States
Individual Site Status
Completed
Facility Name
OrthoIndy, Inc.
City
Greenwood
State/Province
Indiana
ZIP/Postal Code
46143
Country
United States
Individual Site Status
Completed
Facility Name
University Of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Individual Site Status
Completed
Facility Name
Neuroscience Research Center, LLC
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66210
Country
United States
Individual Site Status
Completed
Facility Name
Clinical Pharmacology Study Group
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01605
Country
United States
Individual Site Status
Completed
Facility Name
Oakland Medical Research Center
City
Troy
State/Province
Michigan
ZIP/Postal Code
48085
Country
United States
Individual Site Status
Completed
Facility Name
Excel Clinical Research
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
Individual Site Status
Completed
Facility Name
Las Vegas Clinical Trials, LLC
City
North Las Vegas
State/Province
Nevada
ZIP/Postal Code
89030
Country
United States
Individual Site Status
Completed
Facility Name
Drug Trials America
City
Hartsdale
State/Province
New York
ZIP/Postal Code
10530
Country
United States
Individual Site Status
Completed
Facility Name
M3-Emerging Medical Research, LLC
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27704
Country
United States
Individual Site Status
Completed
Facility Name
M3-Emerging Medical Research, LLC
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27704
Country
United States
Individual Site Status
Completed
Facility Name
University Orthopedics Center
City
State College
State/Province
Pennsylvania
ZIP/Postal Code
16801
Country
United States
Individual Site Status
Completed
Facility Name
Coastal Carolina Research Center
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Individual Site Status
Completed
Facility Name
Coastal Carolina Research Center
City
North Charleston
State/Province
South Carolina
ZIP/Postal Code
29405
Country
United States
Individual Site Status
Completed
Facility Name
Accellacare-Knoxville
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37912
Country
United States
Individual Site Status
Completed
Facility Name
Tekton Research, Inc.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Completed
Facility Name
Wasatch Clinical Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Individual Site Status
Completed
Facility Name
UMHAT Eurohospital Plovdiv OOD
City
Plovdiv
ZIP/Postal Code
4000
Country
Bulgaria
Individual Site Status
Completed
Facility Name
Medical Centre Artmed
City
Plovdiv
ZIP/Postal Code
4002
Country
Bulgaria
Individual Site Status
Completed
Facility Name
UMHAT Pulmed
City
Plovdiv
ZIP/Postal Code
4002
Country
Bulgaria
Individual Site Status
Completed
Facility Name
Medical Centre N. I. Pirogov EOOD
City
Sofia
ZIP/Postal Code
1000
Country
Bulgaria
Individual Site Status
Completed
Facility Name
MHAT St Iv. Rilski
City
Sofia
ZIP/Postal Code
1612
Country
Bulgaria
Individual Site Status
Completed
Facility Name
Synexus Medical Center Sofia
City
Sofia
ZIP/Postal Code
1784
Country
Bulgaria
Individual Site Status
Completed
Facility Name
Fukuoka University Hospital
City
Fukuoka-shi
State/Province
Fukuoka
ZIP/Postal Code
8140180
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kitakyushu General Hospital
City
Kitakyushu-city
State/Province
Fukuoka
ZIP/Postal Code
802-8517
Country
Japan
Individual Site Status
Recruiting
Facility Name
Medical Corporation Kouhoukai Takagi Hospital
City
Okawa-shi
State/Province
Fukuoka
ZIP/Postal Code
831-0016
Country
Japan
Individual Site Status
Recruiting
Facility Name
Hakodate Central General Hospital
City
Hakodate
State/Province
Hokkaido
ZIP/Postal Code
040-8585
Country
Japan
Individual Site Status
Not yet recruiting
Facility Name
Saiseikai Kanagawaken Hospital
City
Yokohama-shi
State/Province
Kanagawa
ZIP/Postal Code
221-0821
Country
Japan
Individual Site Status
Recruiting
Facility Name
Otakibashi Orthopedic Clinic
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
169-0073
Country
Japan
Individual Site Status
Recruiting
Facility Name
Saitama Medical Center
City
Saitama
ZIP/Postal Code
350-8550
Country
Japan
Individual Site Status
Recruiting
Facility Name
Centrum Medyczne Novumed
City
Jablonna
State/Province
Mazowieckie
ZIP/Postal Code
05-110
Country
Poland
Individual Site Status
Completed
Facility Name
ClinicMed Daniluk, Nowak Spolka komandytowa
City
Bialystok
ZIP/Postal Code
15-879
Country
Poland
Individual Site Status
Completed
Facility Name
Zaklad Opieki Zdrowotnej w Boleslawcu
City
Boleslawiec
ZIP/Postal Code
59-700
Country
Poland
Individual Site Status
Completed
Facility Name
Centrum Kliniczno
City
Elblag
ZIP/Postal Code
82-300
Country
Poland
Individual Site Status
Completed
Facility Name
NZOZ Medi Spatz
City
Gliwice
ZIP/Postal Code
44-100
Country
Poland
Individual Site Status
Completed
Facility Name
Medyczne Centrum Hetmanska
City
Hetmanska
ZIP/Postal Code
62064
Country
Poland
Individual Site Status
Completed
Facility Name
PZU Zdrowie S.A. Oddzia¿ Centrum Medyczne Artimed w Kielcach
City
Kielce
ZIP/Postal Code
25-017
Country
Poland
Individual Site Status
Completed
Facility Name
Centrum Medyczne Semper fortis
City
Krakow
ZIP/Postal Code
31-141
Country
Poland
Individual Site Status
Completed
Facility Name
Centermed Krakow Sp. z o.o.
City
Krakow
ZIP/Postal Code
31-530
Country
Poland
Individual Site Status
Completed
Facility Name
ETYKA Osrodek Badan Klinicznych
City
Olsztyn
ZIP/Postal Code
10-117
Country
Poland
Individual Site Status
Completed
Facility Name
RCMed Piotr Opadczuk
City
Sochaczew
ZIP/Postal Code
96-500
Country
Poland
Individual Site Status
Completed
Facility Name
Lubelskie Centrum Diagnostyczne
City
Swidnik
ZIP/Postal Code
21040
Country
Poland
Individual Site Status
Completed
Facility Name
Europejskie Centrum leczenia Chorob Cywilizacyjnych
City
Warszawa
ZIP/Postal Code
02-777
Country
Poland
Individual Site Status
Completed
Facility Name
ETG Warszawa
City
Warszawa
ZIP/Postal Code
02-793
Country
Poland
Individual Site Status
Completed
Facility Name
Spitalul Judetean Caracal
City
Caracal
State/Province
Olt
ZIP/Postal Code
235200
Country
Romania
Individual Site Status
Completed
Facility Name
SC Medicali's SRL
City
Timişoara
State/Province
Timis
ZIP/Postal Code
300362
Country
Romania
Individual Site Status
Completed
Facility Name
SC Medaudio-Optica SRL
City
Râmnicu Vâlcea
State/Province
Valcea
ZIP/Postal Code
240762
Country
Romania
Individual Site Status
Completed
Facility Name
Centrul Medical de Diagnostic si Tratament Ambulatoriu Neomed SRL
City
Brasov
ZIP/Postal Code
500283
Country
Romania
Individual Site Status
Completed
Facility Name
Spital Clinic Dr I Cantacuzino
City
Bucharest
ZIP/Postal Code
020475
Country
Romania
Individual Site Status
Completed
Facility Name
SC Policlinica CCBR SRL
City
Bucharest
ZIP/Postal Code
030463
Country
Romania
Individual Site Status
Completed
Facility Name
SC Centrul Medical Sana SRL
City
Bucuresti
ZIP/Postal Code
011025
Country
Romania
Individual Site Status
Completed
Facility Name
Spitalul Clinic Sf. Maria
City
Bucuresti
ZIP/Postal Code
011172
Country
Romania
Individual Site Status
Completed
Facility Name
Tread Research
City
Parow
State/Province
Cape Town
ZIP/Postal Code
7500
Country
South Africa
Individual Site Status
Completed
Facility Name
Josha Research
City
Bloemfontein
State/Province
Free State
ZIP/Postal Code
9301
Country
South Africa
Individual Site Status
Completed
Facility Name
Welkom Clinical Trial Centre
City
Welkom
State/Province
Free State
ZIP/Postal Code
9460
Country
South Africa
Individual Site Status
Completed
Facility Name
Worthwhile Clinical Trials
City
Benoni
State/Province
Gauteng
Country
South Africa
Individual Site Status
Completed
Facility Name
Midrand Medical Centre
City
Halfway House
State/Province
Gauteng
ZIP/Postal Code
1685
Country
South Africa
Individual Site Status
Completed
Facility Name
Global Clinical Trials
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0001
Country
South Africa
Individual Site Status
Completed
Facility Name
University of Pretoria
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0002
Country
South Africa
Individual Site Status
Completed
Facility Name
Roodepoort Medicross Clinical Research Centre
City
Roodepoort
State/Province
Gauteng
ZIP/Postal Code
1724
Country
South Africa
Individual Site Status
Completed
Facility Name
Sandton Medical Research (Newtown CRC)
City
Sandton
State/Province
Gauteng
ZIP/Postal Code
2196
Country
South Africa
Individual Site Status
Completed
Facility Name
Clinresco Centres (Pty) Ltd.
City
Kempton Park
State/Province
Johannesburg
ZIP/Postal Code
1619
Country
South Africa
Individual Site Status
Completed
Facility Name
Dr Zubar Fazal Ahmed Vawda MD
City
Durban
State/Province
Kwa Zulu Natal
ZIP/Postal Code
4091
Country
South Africa
Individual Site Status
Completed
Facility Name
Synapta Clinical Research Center
City
Durban
State/Province
Kwa-Zulu Natal
ZIP/Postal Code
4001
Country
South Africa
Individual Site Status
Completed
Facility Name
Precise Clinical Solutions
City
Durban
State/Province
Kwa-Zulu Natal
ZIP/Postal Code
4092
Country
South Africa
Individual Site Status
Completed
Facility Name
Aliwal Shoal Medical Centre
City
Umkomaas
State/Province
Kwa-Zulu Natal
ZIP/Postal Code
4170
Country
South Africa
Individual Site Status
Completed
Facility Name
Medicross Langeberg Medical & Dental Centre
City
Kraaifontein
State/Province
Western Cape
ZIP/Postal Code
7570
Country
South Africa
Individual Site Status
Completed
Facility Name
Arthritis Clinical Research Centre
City
Cape Town
ZIP/Postal Code
7405
Country
South Africa
Individual Site Status
Recruiting
Facility Name
Accellacare Yorkshire
City
Shipley
State/Province
Yorkshire
ZIP/Postal Code
BD18 3SA
Country
United Kingdom
Individual Site Status
Completed
Facility Name
Accellacare Warwickshire
City
Coventry
ZIP/Postal Code
CV3 4FJ
Country
United Kingdom
Individual Site Status
Completed
Facility Name
Chapel Allerton Hospital - Leeds Teaching Hospitals NHS Trust
City
Leeds
ZIP/Postal Code
LS7 4SA
Country
United Kingdom
Individual Site Status
Completed

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Information available on the Grünenthal Group Web Site (see URL below for details); according to the European Federation of Pharmaceutical Industries and Associations (EFPIA) Data Sharing Principles.
IPD Sharing URL
https://www.grunenthal.com/en/research-and-development/clinical-trials/data-sharing-clinical-trials

Learn more about this trial

Open-label Trial to Check the Safety and Tolerability of RTX-GRT7039 Injections for Pain Associated With Osteoarthritis of the Knee

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